U.S. Sen. Joni Ernst (R-IA) is on a legislative mission to lower the prices that Americans pay for their prescription drugs and during this congressional session already has introduced four bills toward that realizing that goal.
“I’m working with lawmakers across the aisle on legislation to increase competition in the marketplace, to drive down prescription drug prices, and to close loopholes that allow bad actors to take advantage of the system,” Sen. Ernst said on Feb. 21.
Most recently, Sen. Ernst on Feb. 12 was the lead original cosponsor of the Preserving Access to Cost Effective Drugs (PACED) Act, S. 440, sponsored by U.S. Sen. Tom Cotton (R-AR), to reform the patenting process and protect the nation’s Indian tribes.
If enacted, S. 440 would amend Title 35 of the United States Code to provide that a patent owner may not assert sovereign immunity as a defense in certain actions before the U.S. Patent and Trademark Office, among other purposes, according to the congressional record.
Under the doctrine of “state sovereign immunity,” a state cannot be sued in federal and state court without its consent, as noted by the National Association of Attorneys General, which says a variety of sovereign immunity regimes have been created among the states.
S. 440, which has been referred to the U.S. Senate Judiciary Committee for consideration, would restore the power of the Patent and Trademark Office, federal courts and the International Trade Commission to review patents regardless of sovereign immunity claims “made as part of questionable transactions,” according to Sen. Ernst.
On Feb. 5, Sen. Ernst also was among 27 original cosponsors of the Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2019, S. 340, a bipartisan, bicameral bill that would prevent brand-name pharmaceutical and biologic companies from stifling competition by blocking the entry of lower-cost generic drugs into the market.
Joining Sen. Ernst as a cosponsor of S. 340, which is sponsored by U.S. Sen. Patrick Leahy (D-VT) in the U.S. Senate, are U.S. Sens. Susan Collins (R-ME), Steve Daines (R-MT), Deb Fischer (R-NE), Mike Rounds (R-SD) and Todd Young (R-IN). The same-named H.R. 965 is sponsored by U.S. Rep. David Cicilline (D-RI) in the U.S. House of Representatives and has seven cosponsors, including U.S. Rep. Doug Collins (R-GA).
S. 340 — which has garnered the support of groups including AARP, the American College of Physicians, and the Coalition for Affordable Prescription Drugs, among others — has been placed on the U.S. Senate Legislative Calendar under General Orders. The House version currently is under consideration in two House committees.
Another bipartisan, bicameral bill cosponsored on Jan. 25 by Sen. Ernst is the Right Rebate Act of 2019, S. 205, which U.S. Sen. Ron Wyden (D-OR) sponsored on Jan. 24 in the Senate. U.S. Rep. Kurt Schrader (D-OR) on Jan. 31 sponsored the same-named H.R. 937 in the House.
If enacted, S. 205/H.R. 937 would require drug manufacturers with Medicaid rebate agreements for covered outpatient drugs to disclose drug product information, according to the congressional record summary. Manufacturers currently are subject to civil penalties for knowingly misclassifying drugs, according to the summary, which says they also must compensate for rebates that were initially underpaid as a result of misclassification, regardless of whether such a misclassification was committed knowingly.
Sen. Ernst said the proposed measure would give the U.S. Department of Health and Human Services the authority to reclassify drugs, impose penalties on bad actors, and demand payment from companies that underpay.
The bill has been referred to the U.S. Senate Finance Committee and both the U.S. House Energy and Commerce Committee and the U.S. House Ways and Means Committee for consideration.
Lastly, Sen. Ernst on Jan. 28 cosponsored the bipartisan Preserve Access to Affordable Generics and Biosimilars Act, S. 64, which U.S. Sen. Amy Klobuchar (D-MN) sponsored on Jan. 9 to limit anticompetitive pay-for-delay deals that prevent or delay the introduction of affordable generic versions of branded pharmaceuticals into the marketplace, according to Sen. Ernst’s statement last week.
S. 64 is under consideration by the Senate Judiciary Committee.
“We are pleased that Senator Ernst has made reducing high drug prices a top priority. We particularly applaud the senator’s co-sponsorship of two bills supported by AARP, the CREATES Act and the Preserve Access to Affordable Generics and Biosimilars Act,” said AARP Iowa State Director Brad Anderson, who added that “both bills would improve competition by getting lower priced drugs to market faster, thus lowering prescription drug prices and saving taxpayers money.”